January 2018

Briefs

Azar Confirmed as HHS Secretary

January 29, 2018

The Senate voted 55 to 43 Jan. 24 to confirm former pharmaceutical industry executive Alex Azar as HHS secretary. Support for Azar, who previously served as the department’s deputy secretary during the George W. Bush administration, was divided, with critics voicing concerns over his time as president of pharmaceutical giant Eli Lilly’s U.S. division. He also served as a member of BIO’s board of supervisors.

Pipeline

Twenty Drugs and Devices have Entered a New Trial Phase This Week

January 29, 2018

Company Drug/Device Medical Condition Status
Apexian Pharmaceuticals APX3330 advanced solid tumors Phase I trials initiated
Bavarian Nordic BN-Brachyury cancer metastasis Phase I trials initiated enrolling 10 subjects
Protalex PRTX-100 (PRTX-100-203 Study) persistent/chronic Immune Thrombocytopenia Phase Ib trials initiated enrolling 30 subjects in Europe
IntelGenx Montelukast VersaFilm Alzheimer’s disease Phase IIa trials initiated
Biomarck Pharmaceutical BIO-11006 non-small cell lung cancer Phase II trials initiated in India
Melinta Therapeutics radezolid bacterial vaginosis Phase II trials initiated
TrovaGene PCM-075 + Zytiga metastatic castration-resistant prostate cancer Phase II trials initiated enrolling 25 subjects
Evofem Biosciences Amphora prevention of urogenital chlamydia and gonorrhea in women Phase IIb/III trials initiated enrolling 850 subjects in the U.S.
GC Pharma GC1102 hepatitis B virus infection following liver transplantation Phase II/III trials planned
Swedish Orphan Biovitrum SOBI003 mucopolysaccharidosis type IIIA Fast Track designation granted by the FDA
Astellas Pharma gilteritinib acute myeloid leukemia Orphan Drug designation granted by the EC
BERG BPM31510 pancreatic cancer Orphan Drug designation granted by the FDA
Enzychem Lifesciences EC-18 acute radiation syndrome Orphan Drug designation granted by the FDA
Nohla Therapeutics NLA101 hematopoietic stem cell transplantation Orphan Drug designation granted by the EC
Omeros OMS721 primary Immunoglobulin A nephropathy Orphan Drug designation granted by the EMA
Orphazyme arimoclomol Niemann-Pick disease Type C Rare Pediatric Disease designation granted by the FDA
Genmab daratumumab (Darzalex) + bortezomib, melphalan and prednisone newly diagnosed multiple myeloma Priority Review granted by the FDA
Baxter International Bivalirudin anticoagulant in patients undergoing percutaneous coronary intervention FDA approved
Bristol-Myers Squibb Yervoy (ipilimumab) advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older EC expanded indication approved
Takeda Pharmaceutical Adcetris (brentuximab vedotin) CD30-positive cutaneous T-cell lymphoma EC extended current conditional marketing authorization
Trial Results

Eight Month Median Progression-Free Survival in Array Colorectal Cancer Study

January 29, 2018

Array BioPharma announced updated results from the 30 patient safety lead-in of the Phase III BEACON CRC trial evaluating the triplet combination of encorafenib, in patients with BRAF-mutant metastatic colorectal cancer (CRC) whose disease has progressed after one or two prior regimens. The randomized, open-label, global trial enrolled 30 patients who were treated in the safety lead-in and received the triplet combination (encorafenib 300mg daily, binimetinib 45mg twice daily and cetuximab per label). The confirmed overall response rate (ORR) in patients with the BRAFV600E mutation was 48%, and three patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy. These data represent substantial improvements compared to several separate historical published standard of care benchmarks for this population. In the safety lead-in, the triplet combination was generally well-tolerated. The most common grade three or four AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30). All patients with elevated baseline levels of the tumor markers CEA and CA19-9 had a reduction from baseline, with similar and substantial (median 83% – 96%) reductions across both markers in patients with objective responses and those with stable disease. The enrollment in the randomized portion of the BEACON CRC trial is ongoing.

CWMarketplace

Industry service provider profiles

January 29, 2018

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Contract Research Organizaions
Accell Clinical Research, LLC

Accell Clinical Research, LLC
Culpeper, VA
(540) 321-4051
julia.kondakov@accellclinical.com

Since 2007, Accell has been providing clinical CRO services in phase I-IV trials in Eastern Europe, Russia and CIS.

Celerion

Celerion
Lincoln, NE
(402) 476-2811
info@celerion.com

Celerion is the largest global early clinical research provider, with over 40 years’ experience. Celerion has two strategically placed bioanalytical laboratories in Zürich Switzerland and Lincoln, Nebraska USA.

DZS Clinical Services

DZS Clinical Services
Bound Brook, NJ
(732) 764-6970
gambra@dzs.com

DZS combines a unique brand of flexibility from its services division with its proprietary ClinPlus eClinical Platform.

Pivotal S.L.

Pivotal S.L.
Madrid, Spain
0034 679 488 022
bd@pivotal.es

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. Pivotal currently employs 200 cross-functional professionals.

SGS Life Science Services

SGS Life Science Services
Geneva, Switzerland
+ 41 22 739 91 11
lss.info@sgs.com

SGS has 1,300 employees located in 25 facilities in 14 countries. It has two phase I units with 172 beds, three bioanalytical labs and seven phase II-IV clinical trial management offices.

Investigative Site Networks
PMG Research, Inc.

PMG Research, Inc.
Winston-Salem, NC
(336) 608-3500
awright@pmg-research.com

PMG Research is an Integrated Site Network (ISN) of 10 clinical research facilities. Since its founding in 1979, PMG has conducted over 7,100 research studies.

Technology Solutions
Clinical Conductor

Clinical Conductor
Alpharetta, GA
info@clinithink.com

Founded in 2009, Clinithink is a clinical natural language processing (CNLP) software supplier that gives life sciences organizations and healthcare providers access to unstructured clinical narrative.

DrugDev

DrugDev
Wayne, PA
(610) 650-1890
solutions@drugdev.com

Built around the largest global network of active opted-in investigators, DrugDev’s unified solutions suite optimizes site selection and startup, investigator payments and clinical operations.

Forte

Forte
Madison, WI
(608)826-6000
info@forteresearch.com

Forte provides key solutions for cancer centers, academic medical centers and health systems to unleash their research potential through software, consulting, services and managed infrastructure.

Features

NEJM: Right-to-Try Laws Could Still Undercut FDA Authority, Even if Ineffective

January 22, 2018

While the versions of federal right-to-try legislation pending on Capitol Hill are expected to have a limited impact on access to experimental therapies — and, therefore, limited potential to increase harm to terminal patients — they still represent a broader effort to weaken medical product regulation and FDA oversight, according to a new piece in the New England Journal of Medicine.

Features

FDA to Begin Publishing Clinical Study Reports & Possibly Select CRLs

January 22, 2018

A new FDA pilot program will publish information from sponsor-produced clinical study reports (CSR) — starting with documents volunteered by companies following a drug’s approval — as part of broader agency efforts to boost transparency in clinical trials and streamline the review process.